Specialist QA I Manufacturing Oversight

BioSpace; Boca Raton (FL); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

401K plan with employer match

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

STD and LTD

Paid Holidays

PTO (3 weeks)

Job summary

ADMA Biologics in Boca Raton, FL is seeking a Specialist QA I Manufacturing Oversight to ensure compliance with quality systems through real-time batch record review and review of manufacturing documentation.

The role involves inspecting production areas, releasing plasma pools, and ensuring adherence to SOPs and regulations (21 CFR 11, 210, 211, 600). It requires 1–3 years in pharma/biotech and a Bachelor’s degree; 12-hour shifts and 24/7 coverage rotation.

Qualifications

• Bachelor’s degree required or equivalent experience in pharmaceutical/biotech
• 1–3 years’ experience in pharma/biotech preferred
• Strong attention to detail and regulatory compliance

Responsibilities

• Perform real-time manufacturing batch record review and approval
• Review manufacturing documentation (logs, charts, etc.) for compliance
• Resolve issues on the manufacturing floor and ensure SOP adherence
• Review and release plasma pools to manufacturing
• Audit nitrogen receipt process and other material controls
• Coordinate with QA Management and support 24/7 oversight rotations

Skills

Quality Systems

cGMP compliance

Documentation review

Education

Bachelor's Degree

Tools

LIMS

SAP

Job description

Job Description

ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a Specialist QA I Manufacturing Oversight in Boca Raton, FL.

Specialist QA I Manufacturing Oversight in Boca Raton, FL!

Job Title: Specialist QA I Manufacturing Oversight

Position Summary

The QA Specialist I - Manufacturing Oversight performs manufacturing oversight activities to ensure compliance with policies and procedures. Oversight activities include, but are not limited to, real-time manufacturing batch record review, review of manufacturing documentation (logs, charts, etc.), and resolution of issues on the manufacturing floor.

Essential Functions (ES) And Responsibilities

• Possess an understanding of Quality Systems (e.g., Deviations, Corrective and Preventive Action reports {CAPAs}, Change Controls, and Out of Specifications {OOSs}).
• Perform Quality Assurance review and approval of Event notifications.
• Possess and understanding of cGMP and regulatory compliance as defined in government regulations such as 21 CFR Parts 11, 210, 211, and 600.
• Perform oversight and inspections of active production areas to resolve problems and to ensure compliance with SOPs and policies.
• Review and release of Plasma pools to manufacturing.
• Review all manufacturing support documentation (logbooks, log sheets, charts, etc.)
• Perform review and release of raw materials in LIMS/SAP.
• Perform audits of Nitrogen receipt process.
• Assist with quarantining and release of critical systems, equipment, and controlled environments.
• Assist in other oversight activities, as needed.
• Coordinate and perform any additional activities or projects assigned by QA Management.
• Experience with LIMS and SAP is preferred.
• Perform general oversight of Buildings 1 and 2 (including cold rooms/freezers)
• Rotation amongst QA Specialists to provide 24/7 manufacturing oversight coverage. Required to work 12-hour shifts (07:00 AM to 07:00 PM or 07:00 PM to 07:00 AM). Must be available to support coverage on either shift.

Job Responsibilities or Job Requirements Competencies Ability to follow the cGMPS' and procedures with great attention to detailExperience Requirements

Experience Requirements

1-3 years' experience in pharmaceutical or biotechnology industry or other related industry preferred

Education Requirements

Bachelor's Degree preferred but can be offset by experience.

Preferred Experience Compliance Requirements (ES)

The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.

Job Description Footer

In addition to competitive compensation, we offer a comprehensive benefits package including:

• 401K plan with employer match and immediate vesting
• Medical, Vision, Life and Dental Insurance
• Pet Insurance
• Company paid STD and LTD
• Company Paid Holidays
• 3 Weeks' Paid Time Off (within the first year)
• Tuition Assistance (after the first year)
• Easily accessible to Tri-Rail. Free shuttle to the Boca Tri-Rail station

ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.

ADMA Biologics is an Equal Opportunity Employer.